Communication planning phase

Once the major pieces of the planning phase have been developed, the postplanning phase begins. This phase includes three vitally important steps (1) communicating the plan, (2) implementing the plan, and (3) monitoring progress once the plan is implemented. 

Project management problems typically don t manifest themselves until the project is well underway. But the basis for most problems is established early on, during the project definition and planning phases. In particular, unclear and poorly communicated statements of project objectives, scope, and deliverables will almost always result in a project workplan that, when implemented, does not fulfill the expectations of the client and other stakeholders. In the absence of clear project definition, the stakeholders will set their own expectations, which usually won t match those of the project manager and his or her team members. 

In the concept planning phase (phase 3), the fundamental solutions for the facility structure are created in an iterative approach. For this, the functional and organizational units as well as their mumal correlations and their communication among each other are initially defined in the strucmre planning and visualized in an ideal function chart. Subsequently the production and assembly structures as well as storage and transport concepts are to be specified based on this ideal function chart and on the communication concept. In the following step, spaces and logistics facilities are dimensioned. Here, spaces are... 

Planning phase Customer involvement Communication between tool maker and product developer (customer) 1.1, 2.2, 3.1, 5.1, 7.1 Support for tender preparation, APQP... 

In the Sustain phase, we focus on committing everyone involved in the work environment to adhere to the 5S standards. This includes everyone from production employees to top management. We want to establish a 5S culture of total employee involvement where 5S becomes a habit. We want 5S to become part of the corporatewide communication plan. To accomplish these objectives we need organizationwide training and methods of communication. And we need to standardize these throughout the organization. 

A plan is more than a list of goals, a bar chart, or a schedule of activities. For the business plan to be effective it needs to define how the measures it covers are to be achieved and the resources to achieve them obtained. There may well be supplementary plans for this purpose. The plan or plans also need to define who is to be responsible for achieving the goals and implementing the plans. Once this is done and the provisions communicated to those affected, a method of tracking achievement can be put in place. To track performance effectively the implementation of the plan needs to be phased such that target dates are set for the determination and acquisition of resources, the issue of detail implementation plans, the organization of work, and the completion of individual tasks. 

Direct Fibrinolytics Alfimeprase is a recombinant tmncated form of fibrolase, a fibrinolytic zinc metalloproteinase isolated from the venom of the Southern copperhead snake. It degrades fibrin directly and achieves thrombolysis independent of plasmin formation. This may result in faster recanalization and a decreased risk of hemorrhagic conversion. The initial data on the safety and efficacy of alfimeprase in peripheral arterial occlusion disease appeared very promising, but recent communication from the sponsor revealed that the phase III trials of the drug in peripheral arterial disease and catheter obstruction (NAPA-2 and SONOMA-2) failed to meet their primary and key secondary endpoints of revascularization. A trial for I AT in acute stroke (CARNEROS-1) is planned to begin soon. 

The next phases are detailed planning of restoration measures, planning of project assessment and project implementation. The final phase, utilization, includes maintenance measures, evaluation of project success, adaptive management and the communication of results. Throughout all phases of the project, the general political and societal framework conditions are taken into account. In short, project managers must deal with complex processes and consider the contextual analysis [7]. 

However, not every environmental project requires a comprehensive and elaborate planning document. Usually the contents and the format of the SAP are determined by such factors as contractual requirements, regulatory agency oversight, or by financial constraints. A smaller document that contains the most essential SAP elements in combination with the Laboratory QA Manual may be as functional as a full-scale SAP. Appendix 7 presents an example of a SAP table of contents. A SAP prepared in this format is a very effective document that communicates the information essential for project implementation and assessment phases without being overloaded with information available from other sources. 

The traditional audit may still be useful in that it leads one in the direction of identifying a faulty system or process, and if one chooses one can go further. Using the innovative approach offered by the quality assessment has some limitations in that it is not the current approach used during pharmaceutical and biotech inspections. Mock FDA audits should be used on a routine basis to ensure employees communication skills are sharpened and that the facility is inspection-ready. Preparation for an FDA inspection should begin during product development. It is a continuous process of the QAP, which the company should implement as early as phase I. No amount of resources in the last weeks before an inspection can make up for lack of adequate planning and preparation. 

For studies that have delegated responsibilities to a PI, the study director will rely on that individual to ensure that relevant phase)s) of the study are conducted in accordance with the study plan, relevant SOP, and principles of GLP. The PI should contact the study director when event(s) occur that may affect the objectives defined in the study plan. All communications should be documented. Communication between the study director and the QA is required at different stages of the study. For instance (1) to review study plans (2) to review new and revised SOPs (3) attendance of QA personnel at study initiation meetings and in resolving potential problems related to GLP (4) by responding to inspection and audit reports promptly (5) by indicating corrective action and (6) by necessary liaison with QA staff, and scientific and technical personnel. In certain unforeseen conditions, change of study director becomes essential. Under such conditions, replacement of the study director should take immediate effect. 

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